MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER

Model Number	867246
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported the site had two sentinel events described as death with unknown root cause.The customer was still compiling their report so they did not have much additional information but they were wondering if the transducer field action impacted single wired transducers or cableless transducers.Based on this information, it cannot be determined whether there was any harm related to philips devices.No other clinical information or medical intervention was reported.
Additional Manufacturer Narrative
This report is based on information provided by philips sales personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the avalon us transducer indicating that the site had two sentinel events with unknown root cause.No other clinical information or medical intervention was reported.Based on this information, it cannot be determined whether the noted sentinel events were related to a philips device.Multiple attempts were made to obtain information regarding the circumstances of the event, patient impact, device context of use, evaluation, repair, and operational status with no response from the customer.No further information was provided.Based on the information available, the cause of the reported problem was not able to be established.The reported problem was not confirmed.Multiple attempts were made to obtain the device context of use, evaluation, repair, and operational status with no response from the customer.No further information was provided.

• Brand Name: AVALON US TRANSDUCER
• Common Device Name: AVALON US TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 19643577
• Report Number: 9610816-2024-00388
• Device Sequence Number: 20767030
• Product Code: HGM
• UDI-Device Identifier: 00884838093195
• UDI-Public: (01)00884838093195
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 867246
• Device Catalogue Number: 867246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown